When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial replaced vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mimi PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Device Description

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in onemillimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implant. The implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

AI/ML Overview

This is a 510(k) submission for a medical device (CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a performance study of a diagnostic AI device. Therefore, much of the requested information about acceptance criteria, study design, and AI-specific metrics is not applicable to this document.

However, I can extract the relevant information regarding the basis for substantial equivalence and the "performance data" presented, which primarily focuses on mechanical testing related to the device's physical properties or reference to existing clinical data, rather than a clinical study evaluating diagnostic accuracy.

Here's the breakdown of what can be derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of acceptance criteria and reported device performance in the context of a diagnostic study with specific metrics like sensitivity, specificity, or AUC. The "performance data" refers to the lack of need for new mechanical or clinical testing due to the nature of the submission (expanded indications for an unchanged device substantially equivalent to a predicate).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is not a study assessing the performance of a diagnostic device on a test set. The submission is for an intervertebral body fusion device and focuses on substantial equivalence based on material, design, and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. There is no diagnostic test set with ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There is no diagnostic test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This document is not about a diagnostic AI device and does not involve human readers interpreting images with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This document is for a physical medical implant, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no diagnostic study with a ground truth.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of "Performance Data" from the Document (as it relates to the device):

The document explicitly states:

Mechanical Testing: "No changes have been made to the actual implants and therefore no mechanical testing was performed to help determine substantial equivalence." This implies that prior mechanical testing results for the original CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, or the predicate device (Valeo Spacer System), were deemed sufficient and applicable due to no design changes to the implants themselves.
Clinical Testing: "Published clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, implants was provided in support of this application. The published clinical outcomes demonstrated that the use of PEEK interbody devices for one or two contiguous levels in anterior cervical fusion procedures, as defined above, poses no new or additional risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional clinical testing was required or performed."

Key Takeaway from the FDA Letter:

The FDA's review for K150619 is a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is different from a PMA (Premarket Approval) which often requires extensive clinical trials to prove safety and effectiveness for novel devices.

The "acceptance criteria" here are aligned with the criteria for demonstrating substantial equivalence to a predicate device (K142264 - Valeo Spacer System and K142152 – CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System). The "study that proves the device meets the acceptance criteria" is the comparison to the predicate device and reference to existing data, rather than a new, independent performance study with specific metrics. The claim is that because the device has not changed in design and has similar intended use and technological characteristics to already cleared devices, it poses no new or additional risks.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2015

Orthofix, Incorporated Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K150619

Trade/Device Name: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: August 12, 2015 Received: August 14, 2015

Dear Ms. Volosen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K150619

page 1 of 2

510(k) Number (if known) K150619

Device Name

CONSTRUX Mini PEEK Spacer System CONSTRUX Mini PEEK Ti Spacer System

Indications for Use (Describe)

CONSTRUX Mini PEEK Spacer System

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

CONSTRUX Mini PEEK Ti Spacer System

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the word "ORTHOFIX".

510(k) SUMMARY

PEEK Cervical Interbody Devices

510(k) Owner InformationName:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214.937.2145214-937-3322nataliavolosen@orthofix.com
Registration Number:	3008524126
Contact Person:	Natalia VolosenSenior Regulatory Affairs Specialist
Date Prepared:	September 3, 2015
Name of DeviceTrade Name / ProprietaryName:	CONSTRUX Mini PEEK Spacer SystemCONSTRUX Mini PEEK Ti Spacer System
Common Name:	Intervertebral body fusion deviceSpinal intervertebral body fixation orthosis
Product Code:	ODP, MQP
Regulatory Classification:	Class II per 21 CFR § 888.3080Class II per 21 CFR § 888.3060
Review Panel:	Orthopedic Device Panel
Predicate Devices:	K142264 - Valeo Spacer System, SE 12/8/2014, AmedicaCorporation (primary predicate device)K142152 – CONSTRUX Mini PEEK Spacer System andCONSTRUX Mini PEEK Ti Spacer System (additionalpredicate)No reference devices were used in this submission
Reason for 510(k) Submission:Expanded Indications for Use

Device Description

CONSTRUX Mini PEEK Spacer System:

{5}------------------------------------------------

ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

Intended Use / Indications for Use

CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

CONSTRUX Mini PEEK Ti Spacer System

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. The "R" in "ORTHOFIX" has a registered trademark symbol next to it.

discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

The purpose of this 510(k) submission is to seek clearance to allow one or two contiguous levels use for the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System implants in the cervical spine. No changes have been made to the actual implants and therefore no mechanical testing was performed to help determine substantial equivalence.

PERFORMANCE DATA - Summary of Clinical Test Conducted for Determination of Substantial Equivalence

Published clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, implants was provided in support of this application. The published clinical outcomes demonstrated that the use of PEEK interbody devices for one or two contiguous levels in anterior cervical fusion procedures, as defined above, poses no new or additional risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional clinical testing was required or performed.

Basis of Substantial Equivalence

The CONSTRUX Mini PEEK Spacer system and CONSTRUX Mini PEEK Ti Spacer system has the same intended use, similar indications for use, similar technological characteristics and design, similar materials and the same principles of operation as the Amedica Valeo Spacer System (K142264). The minor differences between CONSTRUX Mini PEEK Spacer system and CONSTRUX Mini PEEK Ti Spacer system implant design and the Amedica Valeo Spacer System (K142264) predicate does not introduce any additional patient risk.

No design changes have been made to CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System since their last 510(k) clearance K142152, SE 1/8/2015. The purpose of this 510(k) submission is to seek clearance to allow one or

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. There is a registered trademark symbol after the word "ORTHOFIX".

two contiguous levels use for the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System implants in the cervical spine.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.